PANNA: OMB Undermines Guidelines on Cancer Risk

Last week, the U.S. Environmental Protection Agency (EPA) revised 20-year old standards for assessing the risks of cancer from exposures to environmental pollutants. The new guidelines acknowledge the mounting evidence that children under 2 years of age are 10 times more likely than adults to get cancer from certain chemicals. Unfortunately, the new guidelines may never see the light of day, because the White House Office of Management and Budget (OMB) has added language to the regulations that will allow industry to block their implementation.

Cancer risk assessment guidelines provide a blueprint for agency regulators to determine the risks of cancer in humans from exposure to a certain chemical and to set allowable residues of pesticides or other chemicals in food, air, water, waste and contaminated sites. When the first risk assessments were adopted in 1986, little was understood about the vulnerability of different subpopulations to adverse health effects from chemical exposure. The new guidelines seek to correct this, "EPA notes that childhood may be a lifestage of greater susceptibility for a number of reasons, such as rapid growth and development that occurs prenatally and after birth, differences related to an immature metabolic system, and differences in diet and behavior patterns that may increase exposure." EPA also designed the guidance to reflect new evidence as it becomes known, "The supplemental guidance is separate from the Guidelines so that it may be more easily updated as scientific understanding about effects of early-life exposures evolve."

The regulations, including the children's supplemental guidelines, were issued by EPA in March 2003. In its review, the agency's Scientific Advisory Board agreed with EPA's conclusion that early-life exposures to chemical pollutants increase cancer risk and recommended the guidelines be finalized as written. But that didn’t happen.

Instead, the guidelines went to OMB for review, and sat there for two years. Finally, OMB added language allowing the chemical industry or an outside party to challenge the way the guidelines were applied for chemical assessment in a process termed "expert elicitation." OMB also inserted the requirement that EPA assessments meet OMB standards for implementation of the Data Quality Act, an obscure piece of legislation written by an industry lobbyist and slipped into an appropriations bill in 2000 with little debate. The Act, which consists of only two sentences, requires OMB to ensure that all information disseminated by the federal government is reliable. So far the Data Quality Act has been used primarily by industry to forestall regulation.

The Washington Post analyzed 39 petitions filed during the first 20 months of the Data Quality Act and found that 32 were filed by regulated industries, business or trade organizations or their lobbyists. Among those was an American Chemistry Council petition that challenged data used by the Consumer Product Safety Commission for a ban on the use of wood treated with heavy metals and arsenic in playground equipment. Another petition, filed for Syngenta, argued that atrazine should not be restricted as an endocrine disruptor, despite hundreds of pages of scientific evidence, because EPA had not yet established a "regulatory endpoint" or official measurement for endocrine disruption.

Consumers, environmental groups and worker advocates argue that the Data Quality Act is biased in favor of industry because it asks the government to use only data that have achieved a level of certainty rare in statistical or epidemiological research. The end result of this high bar is the discounting of scientific information that should trigger regulation. The costs of ignoring new evidence can be steep. Epidemiologist Devra Davis has pointed out, "a goal for public health research is predicting and thus preventing future harm. This purpose takes us out of the realm of pure knowledge and into an arena in which lives are at stake. Our standards of proof must change accordingly."

Children, the developing fetus and other sectors of the population that have been increasingly identified by researchers as particularly vulnerable to chemicals in the environment have waited a long time for this regulation. According to OMB, they may now have to wait even longer.

Sources: US EPA, "Guidelines for Carcinogen Risk Assessment" and Supplemental Guidance on Risks From Early-Life Exposure; OMBWatch, April 4, 2005, http://www.ombwatch.org; New York Times, April 4, 2005; Washington Post, August 14, 2004; Davis, Devra, When Smoke Ran Like Water, Tales of Environmental Deception and the Battle Against Pollution, 2002, Basic Books, New York, NY.Contact: PANNA.

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